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Investigational Scan (HP MRI) and Blood-Based Testing for the Early Detection of Pancreatic Adenocarcinoma in Patients with High-Risk Pancreatic Cysts
Trial Status: active
This study evaluates how well investigational scan called hyperpolarized pyruvate magnetic resonance imaging (HP MRI) works with a series of blood-based tests to detect pancreatic adenocarcinoma early in patients with high-risk pancreatic cysts. Currently, there is no effective way to detect pancreatic adenocarcinoma without doing surgery and testing tissue collected during that surgery. Many patients have surgery for pancreatic cysts at high risk of pancreatic adenocarcinoma but in the end do not have cancer. The HP MRI scan involves an imaging agent called hyperpolarized pyruvate (HP). Pyruvate is a sugar naturally produced by the body. Using new technology, the magnetic properties of pyruvate are able to be changed and injected into the body so the substance can be seen by an MRI scanner even though in all other ways it is identical to the other pyruvate naturally produced by the body. Cancer cells break down pyruvate to use it as energy (metabolize pyruvate) in a different way than healthy cells, and they may be spotted using the HP MRI scan. Blood tests on this trial include looking at deoxyribonucleic acid (DNA) that is released by tumor cells into the bloodstream (circulating tumor deoxyribonucleic acid [ctDNA]), testing that shows the order of genes and proteins, and testing that looks at biomarkers, which are biological molecules that can be a sign of cancer. The HP MRI with a series of blood tests may be an effective way to detect pancreatic adenocarcinoma early and avoid unnecessary surgery.
Inclusion Criteria
Men and women aged > 18 years
Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
Able to provide informed consent
Exclusion Criteria
Pathologic evidence of pancreatic cancer
Pregnant or breast-feeding patients
Refusal or inability to tolerate scan (e.g., anxiety or claustrophobia)
Inability to lay flat or meet the standard requirements of traditional MRI
Bilirubin > 1.5 x upper limit of normal (ULN) (obtained within 6 weeks prior to the study enrollment. The ULN value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay)
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN (obtained within 6 weeks prior to the study enrollment. The ULN value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay)
Albumin < 3 g/dL (obtained within 6 weeks prior to the study enrollment. The ULN value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay)
Gamma-glutamyl transpeptidase (GGT) > 2.5 x ULN if alkaline phosphatase > 2.5 x ULN (obtained within 6 weeks prior to the study enrollment. The ULN value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay)
Renal function with creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
Cardiac: Congestive heart failure with New York Heart Association (NYHA) status ≥ 2, poorly controlled hypertension, a history of clinically significant electrocardiography (EKG) abnormalities, or myocardial infarction within 6 months of study enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT06305728.
I. Individually assess preliminary sensitivity and specificity of HP MRI and a blood-based assay to identify the presence or absence of adenocarcinoma or high-grade dysplasia in patients with high-risk intraductal papillary mucinous neoplasms (IPMNs) who are scheduled to undergo surgical resection.
SECONDARY OBJECTIVES:
I. Estimate the sensitivity and specificity for a composite measure involving all modalities.
II. Evaluate the concordance of postresection pathology location within the pancreas with the results of HP MRI.
III. Preliminary assessment of a serial multicomponent blood assay as an annual assay to detect progression to high grade dysplasia and malignant transformation of IPMNs.
OUTLINE: This is an observational study.
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI within 6 weeks of standard of care (SOC) surgery and/or undergo blood sample collection during screening and follow-up.
After completion of study intervention, patients are followed up annually for 3 years.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMemorial Sloan Kettering Cancer Center
